Job Description
Responsibilities
+ Own operational accountability for study-level time, cost, and quality deliverables for a global Phase II pan-tumor trial with multiple indications and stages.
+ Lead the development and maintenance of the clinical study plan, including critical path activities, interdependencies, and timelines, using Microsoft Project or similar project management tools.
+ Develop and drive the cross-functional Clinical Study Oversight Plan under the guidance of the study team leader, and ensure consistent adherence by internal teams, CROs, and vendors.
+ Provide operational input into protocol profiles, final protocols, and protocol amendments, ensuring feasibility and operational excellence across global regions.
+ Lead and coordinate document review for protocols and amendments, and support or lead related medical writing tasks such as informed consent forms, CRF guidelines, investigator brochures, safety communications, DSURs, and IND...
+ Own operational accountability for study-level time, cost, and quality deliverables for a global Phase II pan-tumor trial with multiple indications and stages.
+ Lead the development and maintenance of the clinical study plan, including critical path activities, interdependencies, and timelines, using Microsoft Project or similar project management tools.
+ Develop and drive the cross-functional Clinical Study Oversight Plan under the guidance of the study team leader, and ensure consistent adherence by internal teams, CROs, and vendors.
+ Provide operational input into protocol profiles, final protocols, and protocol amendments, ensuring feasibility and operational excellence across global regions.
+ Lead and coordinate document review for protocols and amendments, and support or lead related medical writing tasks such as informed consent forms, CRF guidelines, investigator brochures, safety communications, DSURs, and IND...